Building global capacity. Stefano Vella Center for Global Health Istituto Superiore di Sanità - Rome

Transcription

1 Building global capacity Stefano Vella Center for Global Health Istituto Superiore di Sanità - Rome

2 Disclosure Disclosure of speaker interest Merck & Co: Global Therapeutic Forum (2015 & 2016) ViiV: Think Tank 2015 Gilead: Advisory Board Tanzania HIV Test & Treat Program Janssen: Consultant TASC (Global Public Health Medical Education Program)

3 Viral hepatitis is an international public health challenge, comparable to other major communicable diseases, including HIV, tuberculosis and malaria. Despite the significant burden it places on communities across all global regions, hepatitis has been largely ignored as a health and development priority until recently. It will no longer remain hidden, however, with the adoption of the resolution on the 2030 Agenda for Sustainable Development. Target 3 is of particular relevance: it calls for specific action to combat viral hepatitis.

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5 A few lessons from HIV

6 World AIDS Conference DURBAN,

7 Number of lives saved through Global Fund Supported Programs US$ (BILLION) LIVES SAVED (MILLION) 40 22m 20 With significant gains achieved to date, we are on the right side of the tipping point to control HIV, TB and malaria m Amount disbursed (cumulative) 7 Number of lives saved (cumulative)

8 The impact

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11 The AIDS response is at a crucial juncture, both in its immediate trajectory and its sustainability 2.5 million Window of opportunity 2.5 million 2.1 million Number of new HIV Infections in LMICs (millions) Total HIV infections averted Million ,000 Ambitious Fast-Track targets Maintaining 2013 levels of coverage Source: Adapted from UNAIDS Fast-track Report

12 For clear, HIV epidemic will rebound without change in coverage by 2020

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15 Needle Exchange Drucker E, AIDS 1998 Male circumcision Auvert B, PloS Med 2005 Gray R, Lancet 2007 Bailey R, Lancet 2007 Treatment of STIs Grosskurth H, Lancet 2000 Microbicides for women Abdool Karim Q, Science 2010 Oral pre-exposure prophylaxis Grant R, NEJM 2010 (MSM) Baeten J, NEJM 2012 (Couples) Thigpen M, NEJM 2012 (Heterosexuals) Choopanya K, Lancet 2013 (IDU) HIV PREVENTION Female Condoms Male Condoms HIV Counselling and Testing Coates T, Lancet 2000 Sweat M, Lancet 2011 Opioid substitution therapy Mathers BM, Lancet 2010 Treatment for prevention Cohen M, NEJM, 2011 Donnell D, Lancet 2010 Tanser, Science 2013 Behavioural Intervention

16 Test and Treat and Treat All are great. However, we will never get rid of HIV if we do not address the barriers to testing, access to care, retention, and if we forget to focus on key populations

17 Huge progress has been made so far to curb the AIDS epidemic. A mistake would be to consider this as the beginning of the end. We probably are just at the end of the beginning. S. Vella - Addressing barriers to the end of AIDS by Lancet HIV 2015;2( 9): e360 e361.

18 Vella S. Wilson D.. Lancet HIV, Vol 3, September 2016, e

19 Diversity of HIV epidemics: interventions shall be targeted

20 THE DISPLACED

21 HOMELESS

22 SEX WORKERS

23 HIV PREVALENCE IN SEX WORKERS, YEAR 2015

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25 DRUG ADDICTION

26 HIV PREVALENCE IN PEOPLE WHO INJECT DRUGS, YEAR 2015

27 INCARCERATED

28 HIV, TB, HCV Syndemics & Prisons as Amplifiers: Semipermeable Membranes More HIV Tuberculosis Viral Hepatitis (HCV, HBV) STIs Prisons Mental illness Addiction Community

29 HIV PREVALENCE IN MSM, YEAR 2015

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31 EXPLOITED YOUNG WOMEN

32 1.5 billion people live in slums

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34 Innovations in HIV (some of them will be good also for HCV) Drug development Political committment Activism from communities Innovative financing Health Systems research Universal Access & Drug pricing

35 Antiretroviral Drug Approval: AZT ddi ddcd4t NFV DLV APV TDF RTV IDV EFV LPV/r ABC NVP 3TC SQV ETR ENF RAL ATV MVC FTC DRV FPV TPV RPV EVGDTG TAF

36 Long Acting Injectable Nano-Suspensions: TMC278LA (Rilpivirine; PATH) Cabotegravir (GSK 744; ViiV) NNRTI (Rilpivirine) Oral formulation in Complera TM Long acting: up to 3 months? Multiple trials: Dose ranging PK; PK/PD Phase-2: HPTN 076 Integrase inhibitor Similar to Dolutegravir Safe in humans with oral run-in Activity up to 3 months? NHP model efficacy Phase 2: Éclair and HPTN 077

37 Innovations in HIV Drug development Political committment Activism from communities Innovative financing Health Systems research Universal Access & Drug pricing

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39 Innovations in HIV Drug development Political committment Activism from communities Innovative financing Health Systems research Universal Access & Drug pricing

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42 Innovations in HIV Drug development Political committment Activism from communities Innovative financing Health Systems research Universal Access & Drug pricing

43 The Global Fund A 21st-century organization to accelerate the end of HIV, TB and malaria as epidemics The Global Fund is the leading contributor of resources in the fight against AIDS, TB and Malaria. It mobilizes and invests nearly US$4 billion a year to support countries and communities most in need. It has an active portfolio of 496 active grants in over 100 countries, implemented by local experts. Source: Global Fund grant data as of November

44 Innovations in HIV Drug development Political committment Activism from communities Innovative financing Health Systems research Universal Access & Drug pricing

45 HIV care may inform appropriate response to other health threats Demand for services Access to services Health care workers training Support for adherence Infrastructure and equipment Program management Drug and laboratory supplies Linkage to care Community involvement

46 How HIV advances in HIV care can inform other health care models 1. Integrated models of care: from HIV, to HIV + TB, to HIV + TB + HIV co-morbidities to HIV + TB + Co-Morbidities + Co-infections (HCV/HBV) + NCDs 2. Differentiated Models of Care: client-centered approach, to simplify and adapt services to reflect the preferences and expectations of various groups of people living with HIV (PLHIV) while reducing unnecessary burdens on the health system. this model could easily also be applied to HCV care

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48 Health care worker-managed group Client-managed group Facility-based individual Out-of-facility individual

49 Innovations in HIV Drug development Political committment Activism from communities Innovative financing Health Systems research Universal Access & Drug pricing

50 TRIPS: Trade-Related Aspects of Intellectual Property Rights Mandatory patent protection for inventions in all fields of technology for a minimum term of twenty years. However: Members may, in formulating or amending their laws and regulations, adopt measures necessary to protect public health and nutrition, and to promote the public interest in sectors of vital importance to their socioeconomic and technological development, provided that such measures are consistent with the provisions of this Agreement (art. 8)

51 The fall in pricing of HIV medicines, both generic and proprietary, played a crucial role in increasing access to ART in LMIC

52 Universal access to HIV treatment is one of the greatest success stories in medicine (>17 million treated). This should not stand alone, but be repeated for mass treatment of cancer, viral hepatitis and other diseases this time, more quickly 52

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54 Some treatments are simply too important to public health to leave their distribution to the private interests vying against each other Taking a broad, public health perspective on access to medications may provide a better context for policy discussions regarding the pricing of breakthrough pharmaceuticals and create opportunities for a virtuous circle for manufacturers, payers, and patients.

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56 Procurement interventions Pro-generic policies Pricing interventions (voluntary licensing and patent pools) Quality of Generics Quality use of medicines Trade-Related Aspects of Intellectual Property Rights Flexibilities

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58 Suerie Moon, Medicines as global public goods: The governance of technological innovation in the new era of global health, Global Health Governance 2, no. 2: 1-23, Fall 2008/ Spring Public%20Goods.pdf HIV/AIDS has re-framed medicines from being understood as private goods to global public goods. Second (and relatedly), it has legitimised the idea that public health concerns may trump intellectual property protection.

59 HCV ELIMINATION

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61 WHY

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66 HCV ERADICATION THERAPY SHALL IT BE RESERVED TO SPECIAL CLINICAL OR TRANSMISSION CATEGORIES?

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71 We need to keep our eyes wide open on transmission dynamics

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83 it always seems impossible, until its done (N. Mandela)